Protocol summary

Summary
Pain control in patients after coronary artery bypass surgery is the purpose of this study. Sixty eight patients (aged 30-65 years), with 3-vessel disease (3VD), ejection fraction greater than 40% who undergone coronary artery bypass surgery using a heart-lung pump will be entered in the study. One mg oral Lorazepam at the night before surgery and 1 hour before transfer to the operating room and 1 mg/kg intramuscular morphine half an hour before transfer to the operating room given to patients for sedation. All patients underwent coronary artery bypass grafting surgery with the same technique using heart-lung pump arranged.After surgery, patients transferred to cardiac intensive care with tracheal tube and underwent to mechanical ventilation. Patients separate from ventilator and the endotracheal tube is removed between 6-8 hours. Then, patients divide into two equal groups after extubation. For patients in group P, PCA pump containing 3 ampoules of morphine is equivalent to 30 mg infused with speed of 0.02 mg/kg/h. In group M, 0.03 mg/kg bolus morphine given to patients with VPS>3 and repeated 3 times in 1 hour if pain not controlled. Group M will receive infusion of normal saline as placebo. If pain is not controlled after administration of morphine in two groups, intravenous Apotel and Diclofenac suppository are used.In both groups, every 2 hours for 12 hours and then every 4 hours to 24 hours, vital signs including blood pressure and heart rate, pain on the VPS score (Verbal pain scale) and the incidence of complications such as hypoxia, sedation and gastrointestinal effects assessed and recorded.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015012814359N3
Registration date: 2015-04-24, 1394/02/04
Registration timing: prospective

Last update:
Update count: 0
Registration date
2015-04-24, 1394/02/04
Registrant information
Name
Vally Imantalab
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 1666 9064
Email address
vimantalab@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Guilan University of Medical Sciences
Expected recruitment start date
2015-04-30, 1394/02/10
Expected recruitment end date
2015-11-05, 1394/08/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the use of morphine bolus and using a portable infusion pumps for pain management in patients after coronary artery bypass grafting surgery (CABG)
Public title
Pain control after coronary artery bypass grafting surgery (CABG)
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Patients aged 30-65 years;Three vessels disease (3VD) Exclusion criteria:Patients not extubated after 8 hours;Patients requiring reoperation for bleeding ;Patients with advanced heart failure (requiring high-dose postoperative inotropic or need to put intra-aortic balloon pump (IABP)
Age
From 30 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 68
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Block Randomization

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
ٍEthics committee of Guilan University of Medical Sciences
Street address
Shahid Beheshti Freeway
City
Rasht
Postal code
4193833697
Approval date
2015-01-05, 1393/10/15
Ethics committee reference number
1930474204

Health conditions studied

1

Description of health condition studied
Coronary artery disease
ICD-10 code
I25.1
ICD-10 code description
Atherosclerotic heart disease

Primary outcomes

1

Description
Pain
Timepoint
Every 2 hours for 12 hours and then every 4 hours to 24 hours
Method of measurement
Using verbal pain score (VPS).0-10

Secondary outcomes

empty

Intervention groups

1

Description
Intervention 1: Infusion 30 mg morphine sulfate 10 mg/cc with speed of 0.02 mg/kg/h using PCA pump up to 24 hours
Category
Treatment - Drugs

2

Description
Intervention 2: Injection 0.03 mg/kg bolus morphine sulfate 10 mg/cc three time in one hour up to 24 hours
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Heshmat Hospital
Full name of responsible person
Valli Imantalab
Street address
Fifteenth Khordad Street
City
Rasht

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research of Guilan University of Medical Sciences
Full name of responsible person
Abtin Heidarzadeh
Street address
Shahid Beheshti Freeway
City
Rasht
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research of Guilan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Vali Imantalab
Position
Anesthesiologist
Other areas of specialty/work
Street address
Heshmat Hospital
City
Rasht
Postal code
4139638459
Phone
+98 13 3366 3070
Fax
+98 13 3334 5132
Email
aecguilan1392@gmail.com
Web page address
www.arc.gums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Guilan University of Medical Science
Full name of responsible person
Valli Imantalab
Position
Anesthesiologist
Other areas of specialty/work
Street address
Dr.Heshmat Hospital
City
Rasht
Postal code
4193955599
Phone
+98 13 3366 3070
Fax
+98 13 3334 5132
Email
vimantalab@gums.ac.ir; arcguilan1392@gmail.com
Web page address
www.arc.gums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Hedyeh Nemati
Position
Medical laboratory Sciences Technician/ Bachelor's Degree
Other areas of specialty/work
Street address
Poursina Hospital
City
Rasht
Postal code
4193713194
Phone
+98 13 3331 0434
Fax
+98 13 3334 5132
Email
arcguilan1392@gmail.com
Web page address
www.arc.gums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
Loading...